RecruitingNot ApplicableNCT04796792

Ultrasound to Facilitate Stone Passage

Ultrasound Technology to Fragment and Reposition Urinary Stones

Sponsor

University of Washington

Enrollment

140 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Urinary Stone Urinary Calculi

Summary

This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Individuals presenting with at least one kidney stone
Stone with maximum dimension \> 2 mm and ≤ 7 mm as determined by clinical imaging
Individuals with SCI - (Phase 2b only)

Exclusion Criteria16

Individuals under 18 years of age
Individuals who are pregnant or who are trying to get pregnant
Prisoners
with cognitive impairment that would limit their ability to comprehend their role in consent or participation.
Individuals who are unable to read or understand English
Individuals who are unable or unwilling to participate in follow up activities
Individuals who cannot be positioned for ultrasound imaging
Individuals with uncorrected bleeding disorders or coagulopathies
Individuals receiving anticoagulants and who are unable or not willing to temporarily cease the medication for the investigational procedure
Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm ipsilateral to the renal stone targeted by the investigational procedure
Individuals with a solitary kidney
Individuals with an uncorrected urinary tract obstruction
Individuals with an untreated infection
Individuals with a comorbidity risk which, at the discretion of the physician, would make the patient a poor candidate for the investigational procedure
Individuals who have received two previous investigational procedures for the same stone target
Individuals who have undergone the investigational procedure within the last 21 days or still have unresolved AEs from a previous investigational procedure.

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Interventions

DEVICEBurst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)

Novel ultrasound technologies to facilitate passage of stones.This includes Burst Wave Lithotripsy (BWL), a technology to noninvasively fragment urinary calculi within the kidney and ureter, and ultrasonic propulsion, a technology to non-invasively reposition stones within the kidney and ureter. BWL uses short multi-cycle bursts of low amplitude ultrasound to induce stone fracture. This is in contrast to traditional extracorporeal shock wave lithotripsy (SWL), which employs a brief single compression/tensile cycle of high amplitude (shock) waves to achieve stone fracture. Ultrasonic propulsion uses long multi-cycle bursts of low amplitude ultrasound to move stones within the collecting system.